A Multisite Randomized Controlled Trial of Mindfulness Meditation Therapy for PTS

正念冥想疗法治疗 PTS 的多中心随机对照试验

• 批准号: 8453248
• 负责人: James Douglas Bremner
• 金额: --
• 依托单位: TUSCALOOSA VETERANS AFFAIRS MEDICAL CTR
• 依托单位国家: 美国
• 财政年份: 2012
• 资助国家: 美国
• 起止时间: 2012-04-01 至 2014-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8453248
• 关键词: Adherence; Afghanistan; Alabama; Antidepressive Agents; Anxiety; Awareness; Biological Markers; Chronic; Clinical; Clinical Trials; Complementary and alternative medicine; Conduct Clinical Trials; Development; Disease remission; Ensure; Evidence based practice; Evidence based treatment; Freedom; Functional disorder; Gold; Group Therapy; Hour; Intervention; Iraq; Knowledge; Light; Massachusetts; Mediation; Meditation; Mental Depression; Mental Processes; Mental disorders; Methods; Minority; Mission; Monitor; Outcome; Pain; Panic; Participant; Patients; Pilot Projects; Population; Post-Traumatic Stress Disorders; Procedures; Psychotherapy; Randomized; Randomized Controlled Trials; Recruitment Activity; Request for Applications; Research Personnel; Research Priority; Rural; Safety; Single-Blind Study; Sleeplessness; Stress; Symptoms; Therapeutic Effect; Thinking; Training; Trauma; Treatment outcome; Universities; Veterans; War; base; blind; chronic pain; clinical care; clinical research site; clinically relevant; coping; effective therapy; experience; improved; medical schools; mindfulness; mindfulness meditation; mindfulness-based stress reduction; operation; preference; programs; prospective; response; satisfaction; socioeconomics; standard measure; treatment effect; young man; young woman

DESCRIPTION (provided by applicant): A Multisite Randomized Controlled Trial of Mindfulness Mediation Therapy for PTSD Background: Currently, veterans with posttraumatic stress disorder (PTSD) are typically treated with antidepressants which have limited efficacy and yield extremely low remission rates. New and improved treatments are sorely needed, especially in light of the inadequate evidence to support the efficacy of most pharmacologic and most psychotherapy treatments for PTSD. Complementary and Alternative Medicine practices, such as meditation, may fill this void. Several other illnesses often found in association with PTSD, such as chronic pain, anxiety, and depression, have shown positive response to meditation, specifically Mindfulness Based Stress Reduction (MBSR). MBSR is manualized program involving 8 weekly classes and a single 6-hour silent retreat session based on a systematic procedure to develop enhanced non-reactive awareness of the moment-to-moment experience of perceptible mental processes. MBSR is a well tolerated, already well disseminated. MBSR has been shown to be effective in reducing conditions that are commonly associated with PTSD, including pain, depression, anxiety and panic, and insomnia. Methods: We propose a prospective, randomized (1:1), controlled multisite study of MBSR in 180 veterans with PTSD. We will compare the clinical outcomes of MBSR to a credible group therapy control condition called Present Centered Group Therapy (PCGT). We will to evaluate the efficacy of MBSR in the treatment of PTSD, as defined by the Clinician Administered PTSD Scale (CAPS), a gold standard measure that is clinically relevant to PTSD. The CAPS will be rated by a trained assessor who is blind to the whether or not the participant receives the MBSR or PCGT intervention. Secondarily, we will evaluate the effects of MBSR on mindfulness, depression, PTSD symptom clusters, rates of response and evaluate the safety and tolerability of MBRS. We will also explore the subjects' acceptance of and satisfaction with MBSR, whether or not the subjects' treatment preference influences outcome; the stress-immunological-biomarkers as they relate to treatment outcome; and the durability of therapeutic effects of MBSR in the treatment of PTSD. Significance: Operations Enduring Freedom, Iraqi Freedom, and New Dawn have brought in large numbers of young men and women with war-related trauma and PTSD and have renewed our sense of mission. PTSD is a chronic and costly illness and treating PTSD is a VHA priority. Clinical trials of psychotherapeutic treatments for PTSD, particularly MBSR, are needed to fill the gap in knowledge and expand the evidence based treatment alternatives for veterans with PTSD.

描述（由申请人提供）： PTSD背景的正念介导疗法的多站点随机对照试验：目前，具有创伤后应激障碍（PTSD）的退伍军人通常用抗抑郁药治疗，抗抑郁药的功效有限，并且产生极低的缓解率。迫切需要新的和改进的治疗方法，尤其是鉴于证据不足以支持大多数药理和大多数心理治疗对PTSD的功效。互补和替代医学实践（例如冥想）可能会填补这一空白。与PTSD相关的其他几种疾病，例如慢性疼痛，焦虑和抑郁，对冥想表现出积极的反应，特别是基于正念的压力减轻（MBSR）。 MBSR是手动的计划，涉及每周8班和一个6小时的一次无声静修会，基于系统的程序，以提高对可感知心理过程的时刻体验的不反应意识。 MBSR是一种耐受性良好的，已经散布得很好。 MBSR已被证明在减少通常与PTSD相关的疾病中有效，包括疼痛，抑郁，焦虑和恐慌和失眠。方法：我们提出了一个前瞻性，随机的（1：1），对有PTSD的180名退伍军人的MBSR受控的多站点研究。我们将将MBSR的临床结局与称为当前集中群体治疗（PCGT）的可信组治疗控制疾病进行比较。我们将评估MBSR在PTSD治疗中的疗效，如临床医生管理PTSD量表（CAPS）所定义，PTSD量表（CAPS）是一种与PTSD有关的金标准措施。帽子将由受过训练的评估员评为对参与者是否接受MBSR或PCGT干预的看法。其次，我们将评估MBSR对正念，抑郁症，PTSD症状簇的影响，反应率并评估MBR的安全性和耐受性。我们还将探讨受试者对MBSR的接受和满意，无论受试者的治疗偏好是否会影响结果；与治疗结果相关的压力免疫生物标志物； MBSR在PTSD治疗中的治疗作用的持久性。意义：持久自由，伊拉克自由和新黎明的行动引起了许多与战争有关的创伤和PTSD的年轻男女，并重新赋予了我们的使命感。 PTSD是一种长期且昂贵的疾病，治疗PTSD是VHA的优先事项。心理治疗的临床试验 对于PTSD，尤其是MBSR，需要填补知识的空白并扩大具有PTSD退伍军人的基于证据的治疗替代方案。